Drugs Pharma

Alembic Pharmaceuticals gets FDA nod for diclofenac

Alembic FDA nod

HQ Team

December 1, 2022: Alembic Pharmaceuticals, an Indian maker of generic drugs, has received FDA approval for diclofenac medicine used to treat osteoarthritis of the knees.

The Abbreviated New Drug Application (ANDA) Diclofenac Sodium Topical Solution USP, 2%, was filed by Aleor Dermaceuticals (Aleor), which got amalgamated with Alembic, according to a BSE filing.

In March this year Alembic Pharmaceuticals, which earlier held 60% of Aleor Dermaceuticals, acquired the remaining 40% from its joint venture partner Orbicular Pharmaceutical Technologies.

“The approved ANDA is therapeutically equivalent to the referenced drug product, Pennsaid Topical Solution, 2%, of Horizon Therapeutics Ireland DAC.”

Aleor had previously received tentative approval for the ANDA.

Diclofenac Sodium Topical Solution USP, 2%, has an estimated market size of $512 million for twelve months ending Sep 2022, according to IQVIA, a global provider of advanced analytics in healthcare.

Alembic has received 177 ANDA approvals —154 final licenses, and 23 tentative approvals from the FDA.

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